BEAUTIBOND

Agent, Tooth Bonding, Resin

SHOFU DENTAL CORP.

The following data is part of a premarket notification filed by Shofu Dental Corp. with the FDA for Beautibond.

Pre-market Notification Details

Device IDK082744
510k NumberK082744
Device Name:BEAUTIBOND
ClassificationAgent, Tooth Bonding, Resin
Applicant SHOFU DENTAL CORP. 1225 STONE DR. San Marcos,  CA  92078
ContactDavid P Morais
CorrespondentDavid P Morais
SHOFU DENTAL CORP. 1225 STONE DR. San Marcos,  CA  92078
Product CodeKLE  
CFR Regulation Number872.3200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-09-18
Decision Date2008-12-11

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
E23517820 K082744 000
E23517810 K082744 000
E235IEWK0 K082744 000

Trademark Results [BEAUTIBOND]

Mark Image

Registration | Serial
Company
Trademark
Application Date
BEAUTIBOND
BEAUTIBOND
77575762 3667742 Live/Registered
Shofu, Inc.
2008-09-22

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